Hindawi Publishing Corporation Anesthesiology Research and Practice Volume 2014, Article ID 170247, 6 pages http://dx.doi.org/10.1155/2014/170247

Clinical Study Attenuation of Hemodynamic Responses to Laryngoscopy and Tracheal Intubation: Propacetamol versus —A Randomized Clinical Trial

Ali Kord Valeshabad,1 Omid Nabavian,2 Keramat Nourijelyani,3 Hadi Kord,4 Hossein Vafainejad,2 Reza Kord Valeshabad,5 Ali Reza Feili,6 Mehdi Rezaei,2 Hamed Darabi,2 Mohammad Koohkan,2 Poorya Golbinimofrad,2 and Samira Jafari2

1 Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, IL 60612, USA 2 Department of Anaesthesiology, Tehran University of Medical Sciences, P.O. Box 14155-6447, Tehran, Iran 3 Department of Epidemiology of Biostatistics, Tehran University of Medical Sciences, P.O. Box 14155-6447, Tehran, Iran 4 Department of Dermatology, Golestan University of Medical Sciences, Gorgan 4934174515, Iran 5 Zainaldin Martyr Research Center, Gorgan University of Agricultural Sciences and Natural Resources, P.O. Box 15739-49138, Gorgan, Iran 6 Center for Cardiovascular Research, University of Illinois at Chicago, 835 S. Wolcott Avenue, Chicago, IL 60612, USA

Correspondence should be addressed to Omid Nabavian; [email protected]

Received 2 February 2014; Accepted 26 March 2014; Published 13 April 2014

AcademicEditor:D.JohnDoyle

Copyright © 2014 Ali Kord Valeshabad et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The purpose of this study is to assess the effects of propacetamol on attenuating hemodynamic responses subsequent laryngoscopy and tracheal intubation compared to lidocaine. In this randomized clinical trial, 62 patients with the American Anesthesiologists Society (ASA) class I/II who required laryngoscopy and tracheal intubation for elective surgery were assigned to receive propaceta- mol 2 g/I.V./infusion (group P) or lidocaine 1.5 mg/kg (group L) prior to laryngoscopy. Systolic and diastolic blood pressures (SBP, DBP), mean arterial pressure (MAP), and heart rate (HR) were recorded at baseline, before laryngoscopy and within nine minutes after intubation. In both groups P and L, MAP increased after laryngoscopy and the changes were statistically significant (𝑃 < 0.001). There were significant changes of HR in both groups after intubation𝑃 ( < 0.02), but the trend of changes was different between two groups (𝑃 < 0.001). In group L, HR increased after intubation and its change was statistically significant within 9 minutes after intubation (𝑃 < 0.001), while in group P,HR remained stable after intubation𝑃 ( = 0.8). Propacetamol 2 gr one hour prior intubation attenuates heart rate responses after laryngoscopy but is not effective to prevent acute alterations in blood pressure after intubation.

1. Introduction effects through hypothalamus2 [ ]. This drug is safe, cost effective and its beneficial effects for pain management and Propacetamol [4-(acetamido)phenyl N,N-diethylglycinate] is reducing amounts have been confirmed in patients a , which is quickly hydrolyzed by plasma esterase who underwent dental, orthopaedic and gynaecologic surg- to vigorous ; 1 gr propacetamol metabolized to eries [3–8]. 500 mg paracetamol [1]. It has an onset of about half an hour Laryngoscopy and tracheal intubation are among the to an hour, has a half-life of one to four hours, and has most painful processes carried out on the human body which duration effect of six to eight hours. Its optimal effects appear areassociatedwithacutehemodynamicresponses,lastingfor about one hour after injection and its maximum recom- at least ten minutes [3–9]. Sympathoadrenal stimulation and mended dose in adults is 4 grams per day. This drug inhibits subsequent catecholamine release may partially contribute to synthesis in the central nervous system and this hemodynamic instability, which is typically signified by also blocks pain impulses peripherally and has antipyretic an increase in heart rate (HR) and blood pressure (BP) [10]; 2 Anesthesiology Research and Practice however, the main mechanism is not clearly defined. These oximetry, was set for each participant. One hour preceding acutechangesinhemodynamicstatusareparticularlysig- anaesthesiainduction,patientsingroupPreceivedpropac- nificant in patients with preexisting predisposing situations etamol 2 g/IV/infusion diluted in 100 cc of normal saline like hypertension, myocardial infarction, myocardial mal- (N.S). Patients in group L received lidocaine (1.5 mg/kg) function, and cardiovascular diseases [11, 12]. two minutes before anesthesia. The grouping was concealed Various techniques have been examined for attenuat- from anesthesiologist performed intubation and also from ing hemodynamic responses to laryngoscopy and tracheal patients who participated in the study. Only the researcher intubation, including deeper anaesthesia [10], and numerous who recorded hemodynamic variables at studied time points drugs, such as beta blockers [13, 14], calcium channel block- was aware of the grouping that was different from the person ers [15], opioids [16–18], sodium channel blockers [18, 19], who analyzed the data. vasodilators [20], and alpha agonists [21]. Opioids are the The routine protocol for anaesthesia induction was sim- most commonly used drugs with satisfactory outcomes for ilarly applied for both groups using I.V. administration of preventing hemodynamic subsequence of intubation. These midazolam 0.02 mg/kg, 2 𝜇g/kg, sodium thiopental drugs are not cost effective, however, and are associated with 5 mg/kg, and atracurium 0.5 mg/kg. Three minutes after- some unfavourable complications such as nausea, vomiting, wards, laryngoscopy and tracheal intubation were performed consumedly sedation, and respiratory depression [22]. There- by two anesthesiologists, using tracheal tubes number 7– fore, there has been a growing trend to find an effective 7.5 for men and number 6.5–7 for women. Anesthesia was substitutetoreducethesesideeffectsasmuchaspossible maintained based on the operation by means of isoflurane [23, 24]. However, the beneficial effects of propacetamol with or without N2Oandfentanyl50𝜇g each 30 minutes. have been confirmed for postoperative pain management. Hemodynamic status, including systolic and diastolic Thepurposeofthisstudyistoassesstheeffectsofpropac- blood pressures (SBP, DBP), mean arterial pressure (MAP), etamol on attenuating hemodynamic responses subsequent and heart rate were recorded in a prepared check list for each laryngoscopy and tracheal intubation compared to lidocaine, individual in six time points, before drug administration (as which is routinely used in most of operation rooms. baseline), after drug administration (before laryngoscopy), andat1,3,6,and9minutesaftertrachealintubation. 2. Subjects and Methods 2.3. Primary and Secondary Outcomes. The primary outcome 2.1. Study Design, Inclusion and Exclusion Criteria. This was to determine the effects of groups (L versus P) and time single-blind randomized clinical trial was conducted between (before intubation and at 1, 3, 6, and 9 minutes after intuba- January 2010 and September 2011. The study protocol was tion) on MAP and HR. Secondary outcomes were assessment approved by the ethical committee of Tehran University of of changes in SBP, DBP, MAP, and HR before and after drug Medical Sciences (TUMS). The cases were selected among the administration, and also their changes within the 9 min- patients who underwent elective gynecologic and reconstruc- utes after laryngoscopy. The incidence rates of tachycardia tive surgeries in two operating rooms of Imam Khomeini (HR > 120 beat/min) and bradycardia (HR < 60 beat/min), Hospital,inTehran,Iran.Thesecaseshadlaryngoscopy hypertension (MAP > 120 mmHg), and hypotension (MAP < and tracheal intubation before the surgery. The inclusion 70 mmHg) were assessed and compared between two groups. criteria were patients between the ages of 20 and 60 as well as American Anesthesiologists society (ASA) classes 2.4. Statistical Analysis. Results were reported as mean ± I and II. Patients with preexisting conditions were not standard deviation (SD) for quantitative variables and per- included, namely, hard intubation (previous history of hard centages for categorical variables. SBP, DBP, MAP, and HR intubation, laryngoscopic view >II, body mass index >30, were compared using the unpaired 𝑡-test between two studied micrognathia, and macroglossia), diabetic patients with auto- groups. The changes of these variables after drug adminis- nomic dysfunction, patients with renal and liver dysfunction, tration were compared assessed using a paired test. A two- patients with a history of cardiovascular disease, hyper- way analysis of variance (ANOVA) with repeated measures tension, cerebrovascular diseases, respiratory disease (e.g., was conducted to determine the effects of groups (L versus asthma), pheochromocytoma, cushing’s syndrome, P) and time (before intubation and at 1, 3, 6, and 9 minutes addiction, propacetamol or lidocaine contraindications, and after intubation) on MAP and HR. In addition, a repeated hypersensitivity, and patients who needed emergent surgery. measures one-way ANOVA was performed in each group to determinetheeffectsoftimeonMAPandHR.Statistical 2.2. Randomization and Study Protocol. The study protocol analysis was performed using SPSS version 21 (SPSS Inc, was explained in detail for those who met the inclusion Chicago, IL, USA) and statistical significance was accepted criteria. Those who agreed and filled informed consent were at 𝑃 ≤ 0.05. enrolled in the study. A specific code was considered for each patient, and they were randomly allocated to two study 3. Results groups, propacetamol (P) and lidocaine (L). In the operating room setting, a peripheral I.V. line was Of 89 initial patients, 66 patients (Male 32) with the mean age drawn from the patient’s hand, and a ringer lactate (2 cc/kg) of 41 ± 12 years (range: 20–60 years), who met inclusion cri- was administered. A standard monitoring system, including teria, were selected for study procedure and equally divided electrocardiogram and noninvasive blood pressure and pulse into two groups L and P. In total, four patients were removed Anesthesiology Research and Practice 3

Enrollment Assessed for eligibility (n=89)

Excluded (n=23) Not meeting inclusion criteria (n=19) Declined to participate (n=4) Other reasons (n=0)

Randomized (n=66)

Allocation Lidocaine group Propacetamol group n=33) Allocated to intervention ( Allocated to intervention (n=33) Received allocated intervention (n=30) Received allocated intervention (n=32) Did not receive allocated intervention (hard Did not receive allocated intervention (hard intubation) (n=3) intubation) (n=1)

Follow-up

Lost to follow-up (incompliance) (n=0) Lost to follow-up (incompliance) (n=0) Discontinued intervention (n=0) Discontinued intervention (n=0)

Analysis

Analysed (n=30) Analysed (n=32) Excluded from analysis (n=0) Excluded from analysis (n=0)

Figure 1: Study diagram. fromthestudyduetohardintubation(3patientsingroupL Table 1: Patients’ baseline data in each group. and1patientinplacebogroup).Figure 1 shows study fellow diagram. Variables Propacetamol Lidocaine P value (𝑛=32) (𝑛=30) Patients’ demographic data in each group is shown in ± ± Table 1. Two groups did not have significant difference for Age (year) 43 12 39 11 0.2 age, sex, weight, height, ASA class, and endoscopic view (𝑃≥ ASA (I/II) 1/31 2/28 0.6 0.2). HemodynamicstatusincludingSBP,DBP,MAP,andHR Sex (M/F) 15/17 13/17 0.8 before and after drug administration (before laryngoscopy) Weight (kg) 74 ± 10 77 ± 10 0.3 has been summarized in Table 2. SBP, DBP, MAP, and HR Height (cm) 164 ± 15 166 ± 12 0.6 were similar between two groups before drug administration Endoscopic view (I/II) 0.9 (𝑃 ≥ 0.2). In both groups SBP,DBP,and MAP decreased after 20/12 19/11 drug administration (𝑃 < 0.001). In group P HR decreased after drug administration (𝑃 < 0.001),whileingroupLitdid not change significantly𝑃 ( = 0.2). its change was statistically significant within 9 minutes after The trend of SBP, DBP, MAP, and HR changes in each intubation (𝑃 < 0.001).IngroupP,HRremainedstable group has been shown in Figure 2.Therewasasignificant within the 9 minutes after intubation𝑃 ( = 0.8). effect of time on MAP𝑃 ( < 0.001), but there was not a signifi- The incidence rates of hypertension (3.0% versus 20.0%, cant difference between two groups over the time points after 𝑃 = 0.034), hypotension (0.0% versus 20%, 𝑃 = 0.007), and intubation (𝑃 = 0.8). In both groups P and L, MAP increased tachycardia (3.0% versus 20.0%, 𝑃 = 0.034)weresignificantly after laryngoscopy and the changes were statistically signifi- lower in group P as compared to group L (𝑃 < 0.05). cant (𝑃 < 0.001). There were significant effects of groups (P versus L) and time on HR after intubation (𝑃 ≤ 0.02). There 4. Discussion were significant changes of HR in both groups after intu- bation, but the trend of changes was not the same between In the present study, our findings showed beneficial effects of two groups. In group L, HR increased after intubation and preoperative administration of propacetamol on attenuation 4 Anesthesiology Research and Practice

Table 2: Hemodynamic variables including systolic, diastolic, and mean arterial blood pressures (SBP,DBP,MAP) and heart rate (HR) before andafterdrugineachgroup.

Propacetamol (𝑁=32) Lidocaine (𝑁=30) Variables Before After P value Before After P value Systolic blood pressure (mmHg) 125 ± 11 112 ± 22 <0.001 126 ± 21 97 ± 21 <0.001 Diastolic blood pressure (mmHg) 82 ± 10 72 ± 9 <0.001 83 ± 14 65 ± 14 <0.001 Mean arterial blood pressure (mmHg) 96 ± 986± 11 <0.001 97 ± 15 75 ± 17 <0.001 Hear rate (beat/min) 81 ± 872± 5 <0.001 85 ± 17 89 ± 21 0.2

140 140

120 120

100 100

80 80

60 60 DBP (mmHg) DBP SBP (mmHg) SBP 40 40

20 20

0 0 Baseline Before 1 min 3 min 6 min 9 min Baseline Before 1 min 3 min 6 min 9 min intubation intubation

(a) (b) 140 140

120 120

100 100

80 80

60 60 MAP (mmHg)

40 perHR (beat min) 40

20 20

0 0 1 min 3 min 6 min 9 min Baseline Before Baseline Before 1 min 3 min 6 min 9 min intubation intubation Propacetamol Propacetamol Lidocaine Lidocaine (c) (d) Figure 2: Hemodynamic status including systolic, diastolic, and mean arterial blood pressures (SBP, DBP, MAP) and heart rate (HR) within 9 minutes after tracheal intubation in each studied group. of heart rate responses after tracheal intubation compared to effects on hemodynamic stimulations after tracheal intuba- lidocaine. None of the lidocaine or propacetamol was effec- tion. However, there are some reports about the effects of tive to attenuate blood pressure responses after laryngoscopy acetaminophen on hemodynamic changes in subjects with and changes of MAP after laryngoscopy were significant in a regular consumption of acetaminophen. These alterations both groups. includeincreaseinbloodpressureandcardiovascularevents Although favorable effects of propacetamol on post- in subjects consuming acetaminophen [25–28]. In one two- operative pain management have been well documented week randomized crossover trial, acetaminophen (1 g three [3–8], there is no published evidence about its preventive times daily) and not placebo increased systolic and diastolic Anesthesiology Research and Practice 5 blood pressure as determined by ambulatory monitoring Conflict of Interests [28]. However, other authors had reverse opinions [29, 30]. It seems that a single injection of propacetamol could not The authors declare that there is no conflict of interests develop these side effects; however, it was not to attenuate the regarding the publication of this paper. responses after laryngoscopy as well. The exact underlying mechanism of the effect of propac- References etamol on cardiovascular responses is not clear. It might be [1] B. Flouvat, A. Leneveu, S. Fitoussi, B. 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